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An Integrated Approach for Establishing Dosing Recommendations: Paliperidone for the Treatment of Adolescent Schizophrenia

Younis, Islam Rasem PhD*; Laughren, Thomas P. MD; Wang, Yaning PhD*; Mathis, Mitchell MD; Gobburu, Jogarao V. PhD

Journal of Clinical Psychopharmacology: April 2013 - Volume 33 - Issue 2 - p 152–156
doi: 10.1097/JCP.0b013e31828393a8
Original Contributions
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The Food and Drug Administration recently approved Invega for the treatment of schizophrenia in adolescents 12 to 17 years. If dosing recommendations for this population would have been based only on the results of the single efficacy trial included in this program, paliperidone dosing in adolescents might have been limited to 3 mg/d in adolescents less than 51 kg and to 6 mg/d in adolescents greater than or equal to 51 kg. This article provides an illustration of a more integrated approach to arrive at dosing recommendation that included practical considerations, modeling and simulation of data from the clinical trial, and the totality of evidence for both paliperidone and the parent drug, risperidone. On the basis of this integrated approach, the agency approved a starting dose of 3 mg/d in both adolescent weight groups and subsequent dosing in a range of 3 to 6 mg/d for adolescents less than 51 kg and 3 to 12 mg/d for adolescents greater than 51 kg, although the 3-mg dose was not evaluated in the greater than or equal to 51-kg group.

From the *Office of Clinical Pharmacology, Office of Translational Sciences, and †Division of Psychiatry Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring; and ‡Institute for Translational Medicine, Schools of Pharmacy and Medicine, University of Maryland, Baltimore, MD.

Received September 19, 2011; accepted after revision July 3, 2012.

Reprints: Islam R. Younis, PhD, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, 10993 New Hampshire Ave, Bldg 51, Room 2175, Silver Spring, MD 20993 (e-mail: islam.younis@fda.hhs.gov).

© 2013 by Lippincott Williams & Wilkins.